MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-29 for KLEENSPEC 590 PREMIUM VAG SPEC LG CASE 59004 manufactured by Welch Allyn.
[78789218]
The 59004 large vaginal speculum involved in the event was returned to welch allyn for engineering evaluation along with 5 unused vaginal specula still sealed in a polybag. Welch allyn engineering determined the lower bill break to be a very clean break with no sharp edges or stress cracks. The specula was also returned with a broken thumb tab not noted in the complaint and was observed to have discoloration and cracks not consistent with unused specula and scuff marks on both upper and lower blades were observed in the middle of the blade length. Engineering noted some plastic discoloration typical of repeated chemical and or enclave use but also noted the vaginal speculum was decontaminated at welch allyn prior to the engineering evaluation that may have caused or contributed to finding. Note: customer noted vaginal specula was not cleaned or sterilized with anything prior to use. Customer noted speculum was single use. The 5 returned unused vaginal specula from the same lot were reviewed. Visual inspection of all 5 unused 59004 specula show scuff marks consistent with the vaginal speculum involved in event. All 5 of the unused 59004 vaginal specula were examined, under a 25x power microscope, for small hairline cracks. No cracks were observed on any of the 5 unused vaginal specula. A destructive test was performed to try to duplicate the customer complaint. A force of 29 lbs. Was determined to be the amount of force required to break the lower bill. This amount of force exceeds the minimum requirement of the 6 lbs. Force that is utilized in a test conducted at the time of manufacture as noted in the device history record. Based on the lot number of the device, it was determined that the date of manufacture was 2015-09-21. Review of the dhr for the speculum found the lot passed all release testing. A review of customer complaints determined this is the second occurrence of a lower bill break in use since (b)(6) 2010. Both occurrences from same customer over a 2 day period from the same lot and case. The directions for use and device packaging for the vaginal speculum both state "warning: if a speculum is damaged, do not use any specula from the same case. " there have been no prior reported complaints for the 59004 vaginal specula, excluding the the two instances above. Sales since april 2010 show approximately (b)(4) devices sold. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[78789219]
A welch allyn sales representative in the (b)(4) informed welch allyn customer care that a second 59004 kleenspec large disposable vaginal speculum broke inside a patient during an examination. This second vaginal speculum broke the day after the first reported break and is from the same customer, lot, and box as reported on mdr 1316463-2017-00007. Both brakes occurred approximately 2 weeks prior to welch allyn awareness. Welch allyn sales representative identified the issue as a lower bill break. The broken piece was removed from the patient's vagina without incident and the patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2017-00008 |
| MDR Report Key | 6678006 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-06-08 |
| Device Manufacturer Date | 2015-09-21 |
| Date Added to Maude | 2017-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDWARD O'NEIL |
| Manufacturer Street | 4341 STATE STREET ROAD P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEENSPEC 590 PREMIUM VAG SPEC LG CASE |
| Generic Name | KLEENSPEC DISPOSABLE VAGINAL SPECULA, LARGE |
| Product Code | HIB |
| Date Received | 2017-06-29 |
| Returned To Mfg | 2017-06-15 |
| Model Number | 59004 |
| Catalog Number | 59004 |
| Lot Number | 20150921 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET ROAD P.O. BOX 220 SKANEATELES FALLS NY 131530220 US 131530220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-29 |